AccessGUDID - DEVICE: External Pacemaker Analyzer (B33596020000)

GUDID

Device Identifier (DI) Information

Brand Name: External Pacemaker Analyzer
Version or Model: Advance EXPMT 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 960-2000
Company Name: NETECH CORPORATION

Primary DI Number: B33596020000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177242153 *Terms of Use

Device Description: The Advance EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices with recent upgrade to the software version .The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The Advance EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31700	External pacemaker analyser	An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTC	Analyzer, Pacemaker Generator Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961582	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 690cc994-4908-4f0e-8354-c4e5c3f44ec5
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024